The European Medicines Agency is looking more closely at medicines used to treat hair loss and a condition caused by an enlarged prostate over concerns about suicidal thoughts.
The review encompasses finasteride and dutasteride. Finasteride is the main ingredient in Organon’s hair loss product Propecia, and also its product for benign prostatic hyperplasia, Proscar.
The safety review was requested by the French medicines agency, which concluded that while there is no established link between the drug and suicidal ideation, new safety assessments suggest it is “at least a reasonable possibility.”
Dutasteride, also under review by the EMA, has a similar mechanism of action. Products containing the medicine include GSK’s Avodart, which is approved in the US for benign prostatic hyperplasia, but is sometimes used off-label to treat hair loss.
Psychiatric side effects are a known risk of finasteride and dutasteride, according to European regulators. Suicidal ideation was recently added to the product information for both Propecia and Proscar in the EU. But despite warnings in the product information, French regulators argued that new safety reports may “seriously alter the risk profile of finasteride.”
They noted that hair loss is “not a serious condition,” and the medicines are typically given to healthy men.
Organon stood behind the safety of its finasteride products on Friday. The company said in a statement to Endpoints News that it will “work closely with the EMA to support this process.”
“Regulatory agencies around the world thoroughly reviewed the safety and efficacy data for these medicines before their approval, and, together with the company, they have continued to review additional safety and efficacy data in the decades that these products have been on the market as part of routine post-marketing surveillance process,” Organon said.
GSK didn’t respond to a request for comment as of press time.
The EMA is expected to recommend whether the marketing authorizations for finasteride and dutasteride should stay the same, change, or be withdrawn.
The FDA in 2o22 declined a petition to pull Propecia from the market, noting that the request “does not provide reasonable evidence to support a causal association between finasteride and depression.” However, the agency did require a label update adding suicidal ideation and behavior to the drug’s list of possible side effects.
The agency didn’t respond Friday to questions about whether it will open a similar review of finasteride and dutasteride.